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Impact Analysis of Prognostic Stratification for Pulmonary Embolism (iAPP)

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ClinicalTrials.gov Identifier: NCT03002467
Recruitment Status : Terminated (Low recruitment rate)
First Posted : December 23, 2016
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Alessandro Squizzato, Università degli Studi dell'Insubria

Brief Summary:

The Investigator postulate that the use of PESI in addition to routine clinical practice, as opposed to routine clinical practice based on clinical judgment alone, will help physicians to correctly identify PE patients at low-risk of adverse outcomes. Considered that low-risk patients could benefit from a short hospital stay, aim of this study is to demonstrate that the use of PESI will lead physicians to discharge these patients earlier, thus reducing the duration of hospital stay of PE patients (primary outcome).

Outpatients diagnosed with PE at the emergency department (ED) and admitted to participating units represent the target population

As the availability of DOACs may influence the duration of hospital stay, the secondary objectives of the present study are:

  1. to demonstrate that a shorter hospital stay for low-risk PE patients (independently on the method used to identify them) will reduce the incidence of hospital-associated complications and improve patients satisfaction and quality of life, without increasing the incidence of PE-related complications
  2. to demonstrate that the use of PESI, as opposed to clinical judgment alone, will be associated with a greater proportion of patients discharged early (< 72 hours from ED admission) or treated entirely at home (< 24 hours from ED admission).
  3. to demonstrate that the use of DOACs will reduce the duration of hospital stay of PE patients
  4. to demonstrate that the use of DOACs, as opposed to standard treatment, will be associated with a greater proportion of patients discharged early (< 72 hours from ED admission) or treated entirely at home (< 24 hours from ED admission).

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Other: PESI score Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact Analysis of Prognostic Stratification for Pulmonary Embolism: A Randomized Controlled Trial
Study Start Date : September 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

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Arm Intervention/treatment
Experimental: PESI score
treating physicians must formally calculate PESI and report in the clinical record form* each day of hospitalization on top of routine clinical practice (standard care)
Other: PESI score
No Intervention: Standard care
standard care (i.e. no formally calculation of PESI on top)



Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Up to 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with objectively diagnosed PE, both suspected or unsuspected (e.g. during CT for cancer staging and/or follow-up)
  • Age > 18 years
  • Signature of written informed consent

Exclusion Criteria:

  • Children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002467


Locations
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Italy
Cuneo, Italy
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
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Principal Investigator: Alessandro Squizzato, MD PhD Università degli Studi dell'Insubria
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Responsible Party: Alessandro Squizzato, Associate Professor, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03002467    
Other Study ID Numbers: iAPP study
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases